| DESCRIPTION |
Arotide® is a combination of fluticasone propionate and salmeterol xinafoate. These drugs represent 2 classes of medications, a synthetic corticosteroid and a selective, long acting β – adrenergic receptor agonist, that have different effects on clinical and physiological indices. Fluticasone propionate is a synthetic, triflurinated corticosteroid with potent anti-inflammatory activity, which is a glucocorticoid receptor agonist. Glucocorticoid steroids have potent anti-inflammatory actions. In asthmatic patients, the suppression of inflammation within the airways reduces the muscle spasm that narrows the airways. At the same time, swelling and mucus are reduced. Sulmeterol is a long acting beta-adrenergic agonist. β2 agonists are medications that attach to β2 receptors on the smooth muscle cells that surround the airways, causing the muscle cells to relax and opening the airways. |
| INDICATION |
Arotide® is indicated for the treatment and control of asthma in individuals 12 years of age or over, who require continuous treatment. Such patients may include those with frequent asthmatic episodes requiring bronchodilators or those with asthma episodes at night. It is also approved for the treatment of Chronic Obstructive Pulmonary Disease (COPD) associated with Chronic Bronchitis. Arotide® should not be used in case of treating acute case of asthma. |
| DOSAGE AND ADMINISTRATION |
Recommended dosage for adults and adolescents 12 years and above is two inhalations/puff twice daily. |
| SIDE EFFECTS |
The adverse reactions occasionally been observed are upper respiratory tract infection, pharyngitis, headache, palpitations, muscle cramp, candidiasis of the mouth and throat, tremor, throat irritation, hoarseness/dysphonia. |
| CONTRAINDICATIONS |
- The primary treatment of status asthmaticus, or other acute episodes of asthma or COPD where intensive measures are required.
- Hypersensitivity to any of the active substances.
|
| USE IN PREGNANCY AND LACTATION |
There are insufficient data on the use of salmeterol and fluticasone propionate during pregnancy and lactation in humen to assess the possible harmful effects. |
| DRUG INTERACTIONS |
No clinically significant drug interactions have been associated with therapeutic doses of Arotide®. |
| OVERDOSAGE |
There are no data available from clinical trials on overdose with Arotide®. |
| PHARMACEUTICAL PRECAUTION |
Store below 30°C. Keep away from heat or flames. Should not be frozen or placed in direct sunlight. Keep out of reach of children. |
| PACKAGING |
Arotide® 125 Inhaler: Each canister contains 120 metered inhalations. Each metered inhalation contains fluticasone propionate BP 125 mcg and salmeterol xinafoate BP equivalent to salmeterol 25 mcg.
Arotide® 250 Inhaler: Each canister contains 120 metered inhalations. Each metered inhalation contains fluticasone propionate BP 250 mcg and salmeterol xinafoate BP equivalent to salmeterol 25 mcg.

Manufactured by
ESKAYEF BANGLADESH LTD.
AT BEXIMCO PHARMACEUTICALS LTD.
GAZIPUR, BANGLADESH
® REGD. TRADEMARK |
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